Validation of USP Micro test/

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

In Chapter <1227> - Validation of Microbial Recovery…

for Membrane Filtration “The method can be considered validated if the recovery rate… is similar…”

How would you interpret similar? For recovery on Agar medium recovery >70% is the target but no mention for Membrane Filtration.

Any thoughts?

2

Hi losttheplot,

As per USP 32 Harmnize method recovery for inoculated microorganisms is within Factor of 2 with respect to inoculam count.(Positive control).

Regards,
Pankaj Sojitra.